Cefalexin 500mg Capsule POM x21

Generic

Pharmaceutical Product

Systemic antibiotic (oral capsule)

UK Licensed Prescription Only Medicine (POM) with MHRA marketing authorisation under various generic product licences for cefalexin 500mg capsules.
Listed in the British National Formulary (BNF) as an oral cephalosporin antibiotic for systemic use.
Included on the World Health Organization Model List of Essential Medicines as cefalexin for treatment of susceptible bacterial infections.

UK Licensed Prescription Only Medicine (POM) with MHRA marketing authorisation under various generic product licences for cefalexin 500mg capsules.
Listed in the British National Formulary (BNF) as an oral cephalosporin antibiotic for systemic use.
Included on the World Health Organization Model List of Essential Medicines as cefalexin for treatment of susceptible bacterial infections.

Systemic antibiotic (oral capsule)

Description

Cefalexin 500mg Capsule POM x21 is a UK prescription-only generic formulation of cefalexin, a first-generation cephalosporin (β-lactam) antibiotic for oral use. Each hard gelatin capsule contains 500 mg of cefalexin for the treatment of susceptible bacterial infections. Cefalexin interferes with bacterial cell wall synthesis, providing bactericidal activity against many Gram-positive organisms and some Gram-negative organisms. The 21-capsule pack presentation is commonly used for short courses of therapy in primary care and other clinical settings.

Bnefits

Broad clinical experience as a first-generation cephalosporin with a well-characterised safety profile.
Oral capsule formulation allows convenient systemic antibiotic therapy where oral treatment is appropriate.
Active against many common pathogens causing respiratory, urinary, skin/soft tissue, bone and joint infections, when shown to be susceptible.
Useful alternative in patients with certain mild or moderate penicillin allergies, where a cephalosporin is considered appropriate by a prescriber.
Available as generic POM, supporting cost-effective prescribing within primary and secondary care.
Pack size of 21 capsules is suitable for typical short-course treatment regimens as determined by a prescriber.

Indications

Treatment of respiratory tract infections (e.g. bronchitis, certain pneumonias) caused by cefalexin-susceptible organisms.
Treatment of otitis media due to susceptible bacteria.
Treatment of skin and soft tissue infections (e.g. cellulitis, skin abscess, wound infections) caused by susceptible organisms.
Treatment of urinary tract infections (UTIs) caused by cefalexin-susceptible organisms.
Treatment of bone and joint infections caused by susceptible organisms, where oral cefalexin is considered appropriate by a specialist.
Other infections due to cefalexin-susceptible organisms, according to the licensed product information and prescriber judgement.

Composition

Active ingredient: cefalexin (usually present as cefalexin monohydrate; equivalent to 500 mg cefalexin per capsule).
Each capsule contains 500 mg cefalexin as the active substance.
Capsule shell: hard gelatin capsule (colour and imprint may vary by manufacturer; many UK SmPCs describe size 0 hard capsules with coloured body and cap).
Excipients: standard capsule excipients (e.g. lactose and other inactive ingredients) as listed in the individual manufacturer’s SmPC.

Formulation

Pharmaceutical form: hard gelatin capsules for oral administration.
Strength: 500 mg cefalexin per capsule.
Legal category (UK): POM – Prescription Only Medicine.

Packaging

Box containing 21 hard gelatin capsules (commonly in blister strips within a cardboard carton).
UK NHS AMPP listing includes a 21-capsule pack of Cefalexin 500mg capsules supplied via Phoenix Healthcare Distribution Ltd.
Outer carton carries the generic name (Cefalexin 500mg capsules), strength, legal category, batch number and expiry date, with a patient information leaflet enclosed.

Usage

Use only on the prescription and under the supervision of a qualified healthcare professional.
Capsules are intended for oral administration and should generally be swallowed whole with water.
Take exactly as directed by the prescriber in terms of dose, frequency and duration; do not adjust the dose or stop treatment early unless advised by a healthcare professional.
Cefalexin is used to treat bacterial infections and should not be used for viral illnesses such as colds or influenza.
If a dose is missed, follow the advice in the patient information leaflet or that given by the prescriber or pharmacist (typically, take the next dose at the usual time rather than doubling up).
Complete the prescribed course even if symptoms improve before the medication is finished, unless your doctor tells you to stop.
Consult a doctor or pharmacist promptly if severe diarrhoea, rash, breathing difficulty, swelling, jaundice or other concerning symptoms occur during treatment.

Contraindications

Known hypersensitivity to cefalexin, other cephalosporins or any of the excipients.
History of severe immediate hypersensitivity (e.g. anaphylaxis) to penicillins or other β-lactam antibiotics, where cross-sensitivity risk is considered clinically unacceptable.
Use in situations where a cephalosporin is not appropriate according to local antimicrobial guidelines or microbiology results.

Adverse Effects

Gastrointestinal disturbances such as nausea, vomiting, abdominal discomfort and diarrhoea.
Antibiotic-associated colitis, including Clostridioides difficile-associated diarrhoea, which can be serious; persistent or severe diarrhoea should prompt medical review.
Hypersensitivity reactions including rash, urticaria, pruritus, fever and, rarely, severe reactions such as angioedema or anaphylaxis.
Transient liver enzyme elevations, jaundice and, rarely, more significant liver dysfunction.
Blood dyscrasias such as eosinophilia, thrombocytopenia or leucopenia have been reported with cephalosporins.
Headache, dizziness and fatigue have been reported in some patients.
Genital candidiasis or other superinfections may occur with prolonged use due to disturbance of normal flora.

Storage Conditions

Store below 25°C or as specified in the individual manufacturer’s SmPC.
Keep capsules in the original package to protect from moisture and light.
Keep out of the sight and reach of children.
Do not use after the expiry date shown on the packaging; return unused or expired medicine to a pharmacy for safe disposal.

Duration

Duration of treatment must be determined by the prescribing clinician according to the type and severity of infection, patient factors and local guidelines; courses are typically short term (often several days) but may be longer for certain infections as directed by a specialist.

Onset

Antibacterial activity begins shortly after adequate systemic levels are achieved following oral dosing; clinical improvement in susceptible infections is often observed within a few days, although the full course should always be completed as prescribed.